Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma

Last updated: October 30, 2024
Sponsor: Diablo Eye Associates
Overall Status: Terminated

Phase

N/A

Condition

Glaucoma

Open Angle Glaucoma

Treatment

Combined cataract surgery with Hydrus microstent

Combined cataract surgery with iStent Inject W

Clinical Study ID

NCT05583591
COMPETE Trial
  • Ages > 60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of the study is to prospectively evaluate and compare Hydrus microstent to the iStent Inject Wide in combination with cataract surgery in patients with mild to moderate open angle glaucoma. Hydrus and iStent are the two FDA approved trabecular meshwork targeting microstents to treat open angle glaucoma in conjunction with cataract surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • >60 years or older

  • Visually significant cataract

  • Mild to moderate primary open angle glaucoma controlled on medications

  • undergoing cataract surgery with lens implantation and concurrent microstentplacement

  • IOP ≥ 21 mmHg and ≤ 36 mmHg after washout of ocular hypotensive medication(s)

  • CCT 480 to 620μm

  • No prior ocular surgery including corneal refractive surgery

  • No SLT within 6 months of baseline visit, no history of intracameral glaucoma drugeluting implants

  • Visual field mean deviation ≤ -12 dB

  • Optic nerve abnormalities consistent with glaucoma, C/D ratio less than ≤0.8

Exclusion

Exclusion Criteria:

  • Prior intraocular surgery

  • Visual field MD ≥ -12 dB

  • secondary glaucoma including uveitis, traumatic, malignant, neovascular, andcongenital glaucoma.

  • Glaucoma related to elevated episcleral venous pressure including Sturge-Webersyndrome, thyroid eye disease, orbital tumor, and etc.

  • Uncontrolled intraocular pressure on maximum tolerated medical therapy;

  • Unable to perform wash-out IOP

  • Anatomic exclusion of narrow anterior chamber angle (Shaffer grade I-II), otherangle abnormalities including angle closure glaucoma

  • Corneal disease or dystrophy

  • Pathological myopia with degeneration that affects diagnostic imaging

  • Clinically significant ocular pathology or degenerative diseases that affect vision,visual field, or optical coherence tomography of optic nerve.

  • Inability to perform reliable Visual Field and optical coherence tomography.

Study Design

Total Participants: 58
Treatment Group(s): 2
Primary Treatment: Combined cataract surgery with Hydrus microstent
Phase:
Study Start date:
October 01, 2022
Estimated Completion Date:
April 22, 2024

Connect with a study center

  • Diablo Eye Associates

    Walnut Creek, California 94598
    United States

    Site Not Available

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